About this trial
This is an open label Phase 2 study to evaluate the efficacy and safety of ACR-368 as monotherapy or with ultra-low dose gemcitabine (ULDG) sensitization in participants with endometrial cancer.
Eligibility criteria
Qualifiers
Participant must be able to give signed, written informed consent.
Participant must have histologically documented, high-grade endometrial cancer.
All high-grade epithelial endometrial histological subtypes are eligible including: endometrioid (all Grade 3), serous, carcinosarcomas, clear-cell carcinoma, and mixed histologies.
Serous carcinoma or mixed tumors with a majority component of serous carcinoma or carcinosarcoma where the carcinomatous component is serous carcinoma.
Disqualifiers
Participant with known symptomatic brain metastases requiring > 10 mg/day of prednisolone (or its equivalent). Participants with previously diagnosed brain metastases are eligible if they have completed their treatment, have recovered from the acute effects of radiation therapy or surgery prior to the start of ACR-368 treatment, fulfill the steroid requirement for these metastases, and are neurologically stable based on central nervous system imaging ≥ 4 weeks after treatment.
Participant has mesenchymal tumors of the uterus.
Participant has a history of clinically meaningful ascites, defined as history of paracentesis or thoracentesis with therapeutic intent, within 4 weeks of Screening. Subjects with planned therapeutic paracentesis or thoracentesis between Screening and Cycle 1 Day 1 dosing are excluded.
Participant had systemic therapy or radiation therapy within 3 weeks prior to the first dose of study drug.
Trial design
Treatments tested in this trial
- ACR-368
- Gemcitabine
- OncoSignature
Treatment groups
Sponsors and collaborators
Acrivon Therapeutics
Lead sponsor
GOG Foundation
Collaborator